Biopsy device with motorized needle firing

ABSTRACT

A biopsy device comprises a needle, a body portion, and a needle firing assembly. The needle firing assembly is operable to fire the needle distally relative to the body portion. The needle firing assembly includes two translating members, a resilient member, and a motor. The motor is operable to selectively move the first translating member distally and proximally. The second translating member is secured relative to the needle such that the needle and the second translating member translate unitarily. The resilient member compresses as the first translating member is moved distally toward the second translating member. The first translating member is then secured to the second translating and the translating members are moved proximally while holding the resilient member in the compressed state. The second translating member is released from the first translating member when they reach a proximal position, which allows the resilient member to fire the needle distally.

This application is a continuation of U.S. patent application Ser. No.13/086,567, published as U.S. Patent Application Pub. No. 2012/0265095,entitled “Biopsy Device With Motorized Needle Firing,” filed Apr. 14,2011, the disclosure of which is incorporated by reference herein.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. For instance, some biopsy devicesmay be fully operable by a user using a single hand, and with a singleinsertion, to capture one or more biopsy samples from a patient. Inaddition, some biopsy devices may be tethered to a vacuum module and/orcontrol module, such as for communication of fluids (e.g., pressurizedair, saline, atmospheric air, vacuum, etc.), for communication of power,and/or for communication of commands and the like. Other biopsy devicesmay be fully or at least partially operable without being tethered orotherwise connected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRICompatible Surgical Biopsy Device,” published Jun. 12, 2003; U.S. Pub.No. 2006/0074345, entitled “Biopsy Apparatus and Method,” published Apr.6, 2006; U.S. Pub. No. 2007/0118048, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” published May 24, 2007; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Pub. No. 2009/0171242, entitled “Clutch andValving System for Tetherless Biopsy Device,” published Jul. 2, 2009;U.S. Pub. No. 2010/0152610, entitled “Hand Actuated Tetherless BiopsyDevice with Pistol Grip,” published Jun. 17, 2010; U.S. Pub. No.2010/0160819, entitled “Biopsy Device with Central Thumbwheel,”published Jun. 24, 2010; U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010; and U.S. Non-Provisional patent application Ser. No. 12/953,715,entitled “Handheld Biopsy Device with Needle Firing,” filed Nov. 24,2010. The disclosure of each of the above-cited U.S. Patents, U.S.Patent Application Publications, and U.S. Non-Provisional PatentApplications is incorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventor hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements. In thedrawings some components or portions of components are shown in phantomas depicted by broken lines.

FIG. 1 depicts a block schematic diagram showing various components ofan exemplary biopsy device;

FIG. 2 depicts a perspective view of the probe and holster of anexemplary biopsy device coupled together;

FIG. 3 depicts a perspective view of the biopsy device of FIG. 2, withthe probe separated from the holster to expose an underside of the probeand a top side of the holster;

FIG. 4A depicts a side elevational view of the biopsy device of FIG. 2,with the needle in an armed position;

FIG. 4B depicts a side elevational view of the biopsy device of FIG. 2,with the needle in a fired position;

FIG. 5 depicts a top plan view of the holster of the biopsy device ofFIG. 2, with the top housing cover removed;

FIG. 6 depicts an exploded perspective view of the needle firingmechanism of the holster of FIG. 5;

FIG. 7 depicts a side view of the lead screw and the firing tube of theneedle firing mechanism of FIG. 6;

FIG. 8 depicts a cross-sectional end view of cam rails of the holster ofFIG. 5 engaged with the firing tube of FIG. 7;

FIG. 9A depicts a top plan view of the holster of FIG. 5, with theneedle firing mechanism in a pre-armed configuration;

FIG. 9B depicts a top plan view of the holster of FIG. 5, with theneedle firing mechanism in an armed configuration;

FIG. 9C depicts a top plan view of the holster of FIG. 5, with theneedle firing mechanism in a firing configuration;

FIG. 9D depicts a top plan view of the holster of FIG. 5, with theneedle firing mechanism in a fired configuration; and

FIG. 10 depicts a partial perspective view of components of the needlefiring mechanism of FIG. 6, with the needle firing mechanism in thefiring configuration of FIG. 9C.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Biopsy Device

FIGS. 1-4 show an exemplary biopsy device (10). Biopsy device (10) ofthis example comprises a probe (100) and a holster (700). A needle (110)extends distally from probe (100), and is inserted into a patient'stissue to obtain tissue samples as will be described in greater detailbelow. These tissue samples are deposited in a tissue sample holder(300) at the proximal end of probe (100), as will also be described ingreater detail below. It should also be understood that the use of theterm “holster” herein should not be read as requiring any portion ofprobe (100) to be inserted into any portion of holster (700). Whileprongs (102) are used to removably secure probe (100) to holster (700)in the present example, it should be understood that a variety of othertypes of structures, components, features, etc. (e.g., bayonet mounts,latches, clamps, clips, snap fittings, etc.) may be used to provideremovable coupling of probe (100) and holster (700). Furthermore, insome biopsy devices (10), probe (100) and holster (700) may be ofunitary or integral construction, such that the two components cannot beseparated. By way of example only, in versions where probe (100) andholster (700) are provided as separable components, probe (100) may beprovided as a disposable component, while holster (700) may be providedas a reusable component. Still other suitable structural and functionalrelationships between probe (100) and holster (700) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Some variations of biopsy device (10) may include one or more sensors(not shown), in probe (100) and/or in holster (700), that is/areconfigured to detect when probe (100) is coupled with holster (700).Such sensors or other features may further be configured to permit onlycertain types of probes (100) and holsters (700) to be coupled together.In addition or in the alternative, such sensors may be configured todisable one or more functions of probes (100) and/or holsters (700)until a suitable probe (100) and holster (700) are coupled together. Ofcourse, such sensors and features may be varied or omitted as desired.

In some versions as shown in FIG. 1, biopsy device (10) includes avacuum source (800), such as a vacuum pump. By way of example only,vacuum source (800) may be incorporated into probe (100), incorporatedinto holster (700), and/or be a separate component altogether. Inversions where vacuum source (800) is separate from probe (100) andholster (700), vacuum source (800) may be coupled with probe (100)and/or holster (700) via one or more conduits such as flexible tubing.As shown in FIG. 1, vacuum source (800) is in fluid communication withtissue sample holder (300) and needle (110). Thus, vacuum source (800)may be activated to draw tissue into lateral aperture (114) of needle(110). Tissue sample holder (300) is also in fluid communication withcutter (200). Vacuum source (800) may thus also be activated to drawsevered tissue samples through the hollow interior of cutter (200) andinto tissue sample holder (300). Other suitable ways in which vacuumsource (800) may be used will be apparent to those of ordinary skill inthe art in view of the teachings herein. It should also be understoodthat vacuum source (800) may simply be omitted, if desired.

In some versions, vacuum source (800) is provided in accordance with theteachings of U.S. Pub. No. 2008/0214955, the disclosure of which isincorporated by reference herein. In addition or in the alternative,vacuum source (800) may be provided in accordance with the teachings ofU.S. Non-Provisional patent application Ser. No. 12/953,715, thedisclosure of which is incorporated by reference herein. As yet anothermerely illustrative example, vacuum source (800) may be provided inaccordance with the teachings of U.S. Non-Provisional patent applicationSer. No. 12/709,695, entitled “Biopsy Device with Auxiliary VacuumSource,” filed Feb. 22, 2010, the disclosure of which is incorporated byreference herein. Still other suitable ways in which vacuum source (800)may be provided will be apparent to those of ordinary skill in the artin view of the teachings herein.

Biopsy device (10) of the present example is configured to mount to atable or fixture, and be used under stereotactic guidance. Of course,biopsy device (10) may instead be used under ultrasound guidance, MRIguidance, PEM guidance, BSGI guidance, or otherwise. It should also beunderstood that biopsy device (10) may be sized and configured such thatbiopsy device (10) may be operated by a single hand of a user. Inparticular, a user may grasp biopsy device (10), insert needle (110)into a patient's breast, and collect one or a plurality of tissuesamples from within the patient's breast, all with just using a singlehand. Alternatively, a user may grasp biopsy device (10) with more thanone hand and/or with any desired assistance. In some settings, the usermay capture a plurality of tissue samples with just a single insertionof needle (110) into the patient's breast. Such tissue samples may bepneumatically deposited in tissue sample holder (300), and laterretrieved from tissue sample holder (300) for analysis. While examplesdescribed herein often refer to the acquisition of biopsy samples from apatient's breast, it should be understood that biopsy device (10) may beused in a variety of other procedures for a variety of other purposesand in a variety of other parts of a patient's anatomy (e.g., prostate,thyroid, etc.). Various exemplary components, features, configurations,and operabilities of biopsy device (10) will be described in greaterdetail below; while other suitable components, features, configurations,and operabilities will be apparent to those of ordinary skill in the artin view of the teachings herein.

II. Exemplary Probe

As shown in FIGS. 2-4, probe (100) of the present example includes adistally extending needle (110). Probe (100) also includes a chassis(120) and a top housing (130), which are fixedly secured together. Asbest seen in FIG. 3, a gear (140) is exposed through an opening (142) inchassis (120), and is operable to drive cutter actuation mechanism (202)in probe (100). As also seen in FIG. 3, another gear (144) is exposedthrough another opening (146) in chassis (120), and is operable torotate needle (110) as will be described in greater detail below. Gear(140) of probe (100) meshes with exposed gear (740) of holster (700)when probe (100) and holster (700) are coupled together. Similarly, gear(144) of probe (100) meshes with exposed gear (744) of holster (700)when probe (100) and holster (700) are coupled together.

A. Exemplary Needle

Needle (110) of the present example includes a piercing tip (112), alateral aperture (114) located proximal to tip (112), and a hub member(150). Tissue piercing tip (112) is configured to pierce and penetratetissue, without requiring a high amount of force, and without requiringan opening to be pre-formed in the tissue prior to insertion of tip(112). Alternatively, tip (112) may be blunt (e.g., rounded, flat, etc.)if desired. Tip (112) may also be configured to provide greaterechogenicity than other portions of needle (110), providing enhancedvisibility of tip (112) under ultrasound imaging. By way of exampleonly, tip (112) may be configured in accordance with any of theteachings in U.S. Non-Provisional patent application Ser. No.12/875,200, entitled “Echogenic Needle for Biopsy Device,” filed Sep. 3,2010, the disclosure of which is incorporated by reference herein. Othersuitable configurations that may be used for tip (112) will be apparentto those of ordinary skill in the art in view of the teachings herein.

Lateral aperture (114) is sized to receive prolapsed tissue duringoperation of device (10). A hollow tubular cutter (200) having a sharpdistal edge (not shown) is located within needle (110). Cutter (200) isoperable to rotate and translate relative to needle (110) and pastlateral aperture (114) to sever a tissue sample from tissue protrudingthrough lateral aperture (114). For instance, cutter (200) may be movedfrom an extended position to a retracted position, thereby “opening”lateral aperture (114) to allow tissue to protrude therethrough; thenfrom the retracted position back to the extended position to sever theprotruding tissue. While lateral aperture (114) is shown oriented in anupward position in FIG. 1, it should be understood that needle (110) maybe rotated to orient lateral aperture (114) at any desired angularposition about the longitudinal axis of needle (110). Such rotation ofneedle (110) is facilitated in the present example by hub member (150).

Hub member (150) of the present example is overmolded about needle(110), such that hub member (150) and needle (110) rotate and translateunitarily with each other. By way of example only, needle (110) may beformed of metal, and hub member (150) may be formed of a plasticmaterial that is overmolded about needle (110) to unitarily secure andform hub member (150) to needle (110). Hub member (150) and needle (110)may alternatively be formed of any other suitable material(s), and maybe secured together in any other suitable fashion. Hub member (150)includes an annular flange (152) and a thumbwheel (154). Gear (144) isslidably and coaxially disposed on a proximal portion (150) of hubmember (150) and is keyed to hub member (150), such that rotation ofgear (144) will rotate hub member (150) and needle (110); yet hub member(150) and needle (110) may translate relative to gear (144). Gear (144)is rotatably driven by gear (744), as will be described in greaterdetail below. Alternatively, needle (110) may be rotated by rotatingthumbwheel (154). Various other suitable ways in which manual rotationof needle (110) may be provided will be apparent to those of ordinaryskill in the art in view of the teachings herein. It should also beunderstood that rotation of needle (110) may be automated in variousways, including but not limited to the various forms of automatic needlerotation described in various references that are cited herein. Examplesof how needle (110) may be translated longitudinally relative to chassis(120) and top housing (130), particularly by a needle firing mechanism(400), will be described in greater detail below.

It should be understood that, as with other components described herein,needle (110) may be varied, modified, substituted, or supplemented in avariety of ways; and that needle (110) may have a variety of alternativefeatures, components, configurations, and functionalities. A pluralityof external openings (not shown) may also be formed in needle (110), andmay be in fluid communication with second lumen (162). For instance,such external openings may be configured in accordance with theteachings of U.S. Pub. No. 2007/0032742, entitled “Biopsy Device withVacuum Assisted Bleeding Control,” published Feb. 8, 2007, thedisclosure of which is incorporated by reference herein. Cutter (150)may also include one or more side openings (not shown). Of course, aswith other components described herein, such external openings in needle(110) and cutter (150) are merely optional. As yet another merelyillustrative example, needle (110) may be constructed in accordance withthe teachings of U.S. Pub. No. 2008/0214955, the disclosure of which isincorporated by reference herein, and/or in accordance with theteachings of any other reference cited herein.

Probe (100) may also include a valve assembly in fluid communicationwith at least part of needle (110), selectively changing a pneumaticstate of at least part of needle (110) based on any suitable conditionssuch as the longitudinal position of cutter (200). Such a valve assemblymay be constructed in accordance with the teachings of U.S. Pub. No.2010/0317997, the disclosure of which is incorporated by referenceherein, in accordance with the teachings of U.S. Non-Provisional patentapplication Ser. No. 12/953,715, the disclosure of which is incorporatedby reference herein, or otherwise. In addition or in the alternative,valving may be provided by vacuum source (800) and/or a vacuum canister,such as is taught in U.S. Pub. No. 2008/0214955, the disclosure of whichis incorporated by reference herein. Other suitable alternativeversions, features, components, configurations, and functionalities ofneedle (110) will be apparent to those of ordinary skill in the art inview of the teachings herein.

B. Exemplary Cutter Actuation Mechanism

As noted above, cutter (200) is operable to rotate and translaterelative to needle (110) and past lateral aperture (114) to sever atissue sample from tissue protruding through lateral aperture (114).This action of cutter (200) is provided by a cutter actuation mechanism(202). Cutter actuation mechanism (202) is positioned mainly in probe(100) in the present example, though it should be understood that cutteractuation mechanism (202) may be positioned mainly in holster (700)and/or both in probe (100) and holster (700). Cutter actuation mechanism(202) includes meshing gears (140, 740), with gear (740) being driven bymotor (204). Motor (204) is located in holster (700) in the presentexample, though it should be understood that motor (204) mayalternatively be located in probe (100) and/or elsewhere.

By way of example only, cutter actuation mechanism (202) may beconstructed in accordance with the teachings of U.S. Pub. No.2008/0214955, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, cutter actuationmechanism (202) may be constructed in accordance with the teachings ofU.S. Pub. No. 2010/0317997, the disclosure of which is incorporated byreference herein. As yet another merely illustrative example, cutteractuation mechanism (202) may be constructed in accordance with theteachings of U.S. Pub. No. 2010/0292607, entitled “Tetherless BiopsyDevice with Self-Reversing Cutter Drive Mechanism,” published Nov. 18,2010, the disclosure of which is incorporated by reference herein.Alternatively, cutter actuation mechanism (202) may be constructed inaccordance with the teachings of any other reference cited herein. Itshould also be understood that biopsy device (10) may be configured suchthat cutter (200) does not translate (e.g., such that cutter (200)merely rotates, etc.); or such that cutter (200) does not rotate (e.g.,such that cutter (200) merely translates, etc.). As another merelyillustrative example, cutter (200) may be actuated pneumatically inaddition to or in lieu of being actuated by mechanical components. Othersuitable alternative versions, features, components, configurations, andfunctionalities of cutter actuation mechanism (202) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

C. Exemplary Tissue Sample Holder

Tissue sample holder (300) of the present example comprises a pluralityof chambers (not shown) configured to receive tissue samples that aresevered by cutter (200) and communicated proximally through the hollowinterior of cutter (200). Tissue sample holder (300) also includes oneor more removable trays (not shown) that permit a user to remove severedtissue samples from tissue sample holder (300) without having to removetissue sample holder (300) from chassis (120). Tissue sample holder(130) further includes a rotatable manifold (not shown) that is in fluidcommunication with vacuum source (800) and cutter (200) and that isrotatable to successively index the chambers to cutter (200). Inparticular, the manifold is rotated by a tissue sample holder rotationmechanism (302), which is driven by a motor (304). It should beunderstood that at least part of tissue sample holder rotation mechanism(302) and/or motor (304) may be incorporated into probe (100), intoholster (700), or into both probe (100) and holster (700).

By way of example only, tissue sample holder (300) may be constructedand operable in accordance with the teachings of U.S. Pub. No.2008/0214955, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, tissue sample holder(300) may be constructed and operable in accordance with the teachingsof U.S. Pub. No. 2010/0160824, entitled “Biopsy Device with DiscreteTissue Chambers,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein. As yet another merely illustrativeexample, tissue sample holder (300) may be constructed an operable inaccordance with the teachings of U.S. Pub. No. 2008/0221480, entitled“Biopsy Sample Storage,” published Sep. 11, 2008, the disclosure ofwhich is incorporated by reference herein.

In some other versions, tissue sample holder (300) does not include arotatable manifold. In some such versions, tissue sample holder (300) isconstructed in accordance with the teachings of U.S. Provisional PatentApp. No. 61/381,466, entitled “Biopsy Device Tissue Sample Holder withRemovable Basket,” filed Sep. 10, 2010, the disclosure of which isincorporated by reference herein. Still other suitable ways in whichtissue sample holder (300) may be constructed and operable will beapparent to those of ordinary skill in the art in view of the teachingsherein.

III. Exemplary Holster

As shown in FIGS. 2-10, holster (700) of the present example includes atop housing cover (702), side panels (704), and a housing base (706),which are fixedly secured together. As best seen in FIG. 3 and as notedabove, gears (740, 744) are exposed through top housing cover (702), andmesh with gears (140, 144) of probe (100) when probe (100) and holster(120) are coupled together. In particular, gears (740, 140) drive cutteractuation mechanism (202); while gears (744, 144) are employed to rotateneedle (110). Holster (700) also includes a firing rod (730) and fork(732), which couple with needle (110) and fire needle (110) distally aswill be described in greater detail below.

All motors (204, 304, 402) referred to herein are contained withinholster (700) in the present example and receive power from an externalsource via cable (720). In addition or in the alternative, data may becommunicated via cable (720) from holster (700) and/or to holster (700)as desired. In some other versions, motors (204, 304, 402) are poweredby one or more batteries located within holster (700) and/or probe(100). It should therefore be understood that, as with other componentsdescribed herein, cable (720) is merely optional. As yet another merelyillustrative variation, motors (204, 304, 402) may be poweredpneumatically, such that cable (720) may be substituted with a conduitcommunicating a pressurized fluid medium to holster (700). As stillother merely illustrative variation, cable (720) may include one or morerotary drive cables that are driven by motors (204, 304, 402) that arelocated external to holster (700). It should also be understood that twoor three of motors (204, 304, 402) may be combined as a single motor.Other suitable ways in which various mechanisms (202, 302, 400) may bedriven will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

A. Exemplary Needle Rotation Mechanism

As noted above, rotation of gear (744) provides rotation of needle (110)relative to probe (100). In the present example, gear (744) is rotatedby rotating knob (710). In particular, knob (710) is coupled with gear(744) by a series of gears (not shown) and shafts (not shown), such thatrotation of knob (710) rotates gear (744). A second knob (710) extendsfrom the other side of holster (700). By way of example only, such aneedle rotation mechanism may be constructed in accordance with theteachings of U.S. Pub. No. 2008/0214955, the disclosure of which isincorporated by reference herein. As another merely illustrativeexample, a needle rotation mechanism may be constructed in accordancewith the teachings of U.S. Pub. No. 2010/0160819, the disclosure ofwhich is incorporated by reference herein. In some other versions,needle (110) is rotated by a motor. In still other versions, needle(110) is simply rotated by rotating thumbwheel (154). Various othersuitable ways in which rotation of needle (110) may be provided will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that some versions may provide norotation of needle (110).

B. Exemplary Needle Firing Mechanism

Holster (700) of the present example further includes a needle firingmechanism (400), which is operable to fire needle (110) from a loadedposition as shown in FIG. 4A to a fired position as shown in FIG. 4B. Byway of example only, such firing may be useful in instances where biopsydevice (10) is mounted to a stereotactic table fixture or other fixture,with tip (112) adjacent to a patient's breast, such that needle firingmechanism (400) may be activated to drive needle (110) into thepatient's breast. Needle firing mechanism (400) may be configured todrive needle (110) along any suitable range of motion, to drive tip(112) to any suitable distance relative to fixed components of probe(100). Needle firing mechanism (400) of the present example is activatedby activation buttons (760) and arming buttons (750). Activation buttons(760) comprise thin film switches presented on side panels (704) ofholster (700). In some versions activations buttons (760) are on bothsides of holster (700) while in other versions activation buttons (760)are either on just one side of holster (700) or are located elsewhere(e.g., remote user interface, at vacuum source (800) or elsewhere,etc.). Activation buttons (760) are operable to selectively activatemotor (402) as will be described in greater detail below. Arming buttons(750) are also provided on both sides of holster (700) in the presentexample, and are mechanically movable transversely relative to sidepanels (704). Each arming button (750) includes a bellows (752) thatprovides a fluid tight seal with side panel (704). Of course, eithertype of button (750, 760) may have various other components, features,configurations, and operabilities.

In the present example, needle firing mechanism (400) is coupled withneedle (110) via a firing rod (732) and a firing fork (732). Firing rod(732) and firing fork (734) are unitarily secured together bycomplementary flats (736, 737) and a pin (738). Firing fork (732)includes a pair of prongs (734) that receive hub member (150) of needle(110) therebetween. Prongs (734) are positioned between annular flange(152) and thumbwheel (154), such that needle (110) will translateunitarily with firing rod (730) and fork (732). Prongs (734)nevertheless removably receive hub member (150), such that fork (732)may be readily secured to hub member (150) when probe (100) is coupledwith holster (700); and such that hub member (150) may be readilyremoved from fork (732) when probe (100) is decoupled from holster(700). Prongs (734) are also configured to permit hub member (150) torotate between prongs (734), such as when knob (710) is rotated tochange the angular orientation of lateral aperture (114). Other suitablecomponents, configurations, and relationships will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

FIGS. 5-10 show components of needle firing mechanism (400) in greaterdetail. As best seen in FIG. 6, needle firing mechanism (400) of thisexample includes motor (402), a firing tube (420), a coupling (440), anda coil spring (460). As will be described in greater detail below, motor(402) is operable to selectively couple firing tube (420) with coupling(440), thereby compressing coil spring (460). Motor (402) is furtheroperable to retract needle (110) to the loaded position shown in FIG.4A. Motor (402) is then operable to decouple coupling (440) from firingtube (420), allowing coil spring (460) to fire needle (110) distally tothe fired position shown in FIG. 4B. Of course, a variety of other typesof resilient or biasing components may be used in addition to or in lieuof coil spring (460).

Still referring to FIG. 6, motor (402) includes an integral drive gear(404), such that motor (402) rotates drive gear (404) when activated.Drive gear (404) meshes with intermediate gear (406), which is supportedin recess (770) of housing base (706) by bushings (408). Intermediategear (406) meshes with nut gear (410), which is supported in recess(772) of housing base (706) by bushings (412). Nut gear (410) includesinternal threading (414) and is coaxially disposed about a shaft (422)that extends proximally and unitarily from firing tube (420). Inparticular, shaft (422) includes external threading (424) thatcomplements internal threading (414) of nut gear (410). As will bedescribed in greater detail below, shaft (422) does not rotate relativeto housing base (706) in this example. It should therefore be understoodthat rotation of nut gear (410) causes firing tube (420) to translatelongitudinally. In other words, motor (402) may be activated totranslate firing tube (420) distally or proximally, depending on thedirection in which motor (402) rotates drive gear (404). A retainer(780) is secured to housing base (706) to retain motor (402), gears(404, 406, 410), and bushings (408, 412) relative to housing base (706).

As best seen in FIG. 7, firing tube (420) further includes a proximalinterior wall (430), a pair of opposing elongate slots (432), a pair ofpawl notches (434) associated with slots (432), and an alignment notch(436). As best seen in FIG. 8, housing base (706) includes a pair ofopposing inwardly projecting cam rails (782) that are disposed inelongate slots (432) of firing tube (420). Rails (782) permit firingtube (420) to translate relative to housing base (706) but preventfiring tube (420) from rotating relative to housing base (706). Ofcourse, a variety of other types of structures, components, features,etc. may be used to provide such operability, if desired.

Coupling (440) is secured to firing rod (730) and pin (738), such thatcoupling (440) translates unitarily with rod (730), pin (738), fork(732), and needle (110). Coupling (440) includes an annular flange (442)and a cap member (444). Cap member (444) includes an alignmentprotrusion (446) that complements alignment notch (436) of firing tube(420). Coupling (440) also includes a pair of pawls (450) that areresiliently biased to project opposingly outwardly by a spring (452). Ofcourse, a variety of other types of resilient or biasing components maybe used in addition to or in lieu of coil spring (452). Cap member (444)secures pawls (450) and spring (452) to coupling while allowing pawls(450) to move transversely as spring (452) is compressed anddecompressed. In particular, and as will be described in greater detailbelow, pawls (450) are sized, positioned, and configured to snap intopawl notches (434) of firing tube (420) as firing tube (420) is advanceddistally; then to be deflected inwardly by rails (782) as firing tube(420) is retracted proximally.

Referring back to FIG. 6, needle firing mechanism (400) of the presentexample further includes a transverse bar (470) that is positionedbetween buttons (750) and that is movable transversely relative tohousing base (706). A pair of spacers (472) are positioned between thefree ends of transverse bar (470) and buttons (750). Each free end oftransverse bar (470) includes a post (474) that is received in acorresponding recess (476) of spacer (472). A pair of coil springs (478)are positioned coaxially about transverse bar (470). Each coil spring(478) resiliently bears against a corresponding spacer (472) and housingbase (706). Coil springs (478) are thus configured to bias transversebar (470) to a transversely centered position relative to housing base(706). Of course, a variety of other types of resilient or biasingcomponents may be used in addition to or in lieu of coil springs (478).As also shown in FIG. 6, transverse bar (470) includes a pair of upperrecesses (480 a, 480 b) and a pair of lower recesses (484 a, 484 b).Upper recesses (480 a, 480 b) are separated by an upper protrusion(482); while lower recesses (484 a, 484 b) are separated by a lowerprotrusion (486). As shown in FIGS. 5, 9A-9B, and 9D, transverse bar(470) is configured such that protrusions (482, 486) are centered on avertical plane (coming out of the page) that is aligned with thelongitudinal axis of shaft (422), firing tube (420), coupling (440),firing rod (730), and pin (738) when transverse bar (470) is centered byopposing resilient biases of coil springs (478).

In an exemplary operation of needle firing mechanism (400), componentsof needle firing mechanism (400) are initially in the positions shown inFIG. 5. The user then activates one of buttons (760) to arm needlefiring mechanism (400). This causes motor (402) to rotate drive gear(404) in a first direction, which through intermediate gear (406) causesnut gear (410) to rotate in the same first direction. This rotation ofnut gear (410) advances firing tube (420) distally, due to interactionbetween internal threads (414) of nut gear (410) and external threads(424) of shaft (422). Firing tube (420) eventually reaches the positionshown in FIG. 9A. As firing tube (420) advances from the position shownin FIG. 5 to the position shown in FIG. 9A, coil spring (460) iscompressed between proximal interior wall (430) of firing tube (420) andcoupling (440). In addition, as firing tube (420) advances from theposition shown in FIG. 5 to the position shown in FIG. 9A, pawls (450)are deflected inwardly by the distal end of firing tube (420) and thensnap outwardly into pawl notches (434) of firing tube (420) once firingtube (420) reaches the position shown in FIG. 9A. This inward deflectionand outward snapping is facilitated by coil spring (452), which providesan outward bias to pawls (450) while still allowing pawls (450) to bemoved inwardly toward each other. It should also be understood that, asfiring tube (420) advances from the position shown in FIG. 5 to theposition shown in FIG. 9A, interaction between alignment notch (436) andalignment protrusion (446) ensures that firing tube (420) and coupling(440) are properly rotationally aligned, thereby ensuring that pawls(450) reach pawl notches (434) when firing tube (420) reaches thedistal-most position shown in FIG. 9A.

After having reached the configuration shown in FIG. 9A, where firingtube (420) has engaged coupling (440), the operation of motor (402) isreversed such that drive gear (404) and nut gear (410) are rotated in asecond direction that is opposite to the first direction. In someversions, this requires a separate activation of at least one button(760). In some other versions, a single activation of button (760)causes motor (402) to drive firing tube (420) to the position in FIG. 9Aand automatically reverse as soon as it reaches that position. Asanother merely illustrative example, a user must hold down at least onebutton (760) the entire time to activate motor (402) to drive firingtube (420) to the position in FIG. 9A and automatically reverse as soonas it reaches that position. In versions where motor (402) automaticallyreverses as soon as firing tube (420) reaches the position shown in FIG.9A, there are various ways in which such automatic reversal may beprovided. By way of example only, an encoder, proximity sensor, motorload detection algorithm, and/or various other components/techniques maybe used to provide automatic reversal of motor (402). It should also beunderstood that a sensor may be used to detect latching of pawls (450)to firing tube (420), and this data may be used to trigger reversal ofmotor (402). As yet another merely illustrative example, biopsy device(10) may provide an alert to a user (e.g., a beep, a light, a loud clickwhen pawls (450) snap into engagement with firing tube (420), etc.) whenfiring tube (420) reaches the position shown in FIG. 9A, such that theuser must then provide an input (e.g., through one or more buttons (750,760) and possibly an additional mechanical safety, etc.) to cause motor(402) to reverse in order to continue the firing process.

With nut gear (410) being rotated in the second direction, firing tube(420) is retracted proximally, due to interaction between internalthreads (414) of nut gear (410) and external threads (424) of shaft(422). Firing tube (420) eventually reaches the armed position shown inFIG. 9B. In this configuration, coil spring (460) remains compressedbetween proximal interior wall (430) of firing tube (420) and coupling(440), storing significant potential energy that is resisted byengagement of pawls (450) with firing tube (420). Pawls (450) are justdistal to rails (782) and are still engaged with firing tube (420) inthe configuration shown in FIG. 9B. In addition, transverse bar (470) ispositioned and configured to restrict further proximal movement offiring tube (420). In particular, with transverse bar (470) beingcentered by springs (478), lower protrusion (486) is positioned justproximal to the proximal end (426) of shaft (422); and along alongitudinal axis passing through shaft (422). While only upperprotrusion (482) can be seen in FIG. 9B, it should be understood thatlower protrusion (486) is just beneath upper protrusion (482). Ofcourse, in some other versions upper protrusion (482) may be positionedjust proximal to the proximal end (426) of shaft (422); and along alongitudinal axis passing through shaft (422). In the event that motor(402) is inadvertently activated to continue translating firing tube(420) proximally, the proximal end (426) of shaft (422) will almostimmediately run into lower protrusion (486), which will prevent furtherproximal movement of firing tube (420). In other words, firing tube(420) cannot move further proximally until lower protrusion (486) ismoved out of the way as described in further detail below. It shouldalso be understood that these components are configured such that pawls(450) remain engaged with firing tube (420) until lower protrusion (486)is moved out of the way as described in further detail below.

After needle firing mechanism (400) has reached the armed configurationshown in FIG. 9B, needle firing mechanism (400) is ready to be fired.Biopsy device (10) may include one or more user feedback features (e.g.,one or more lights, one or more speakers or other sound emittingcomponents, etc.) to alert the user that needle firing mechanism (400)has reached the armed configuration. In order to fire needle firingmechanism (400), the user must hold in one of buttons (750) whileactivating another button (760). This will allow firing of needle firingmechanism (400) as shown in FIG. 9C. While the button (750) on theright-hand side of holster (700) is shown as depressed in FIG. 9C, itshould be understood that the same operation may be provided bydepressing the button (750) on the left-hand side of holster (700). Thispressing of button (750) pushes transverse bar (470) such thattransverse bar (470) moves laterally relative to holster (700). Thislateral movement of transverse bar (470) moves lower protrusion (486)out of the way relative to the proximal end (426) of shaft (422). Thiscan be better seen in FIG. 10, which shows lower recess (484 a)providing clearance for further proximal movement of proximal end (426)of shaft (422). With such clearance being provided, motor (402) isactivated to translate firing tube (420) further proximally to thepositions shown in FIGS. 9C and 10. With firing tube (420) in thisposition, pawls (450) are brought into contact with rails (782), whichpush pawls (450) inwardly toward each other. In particular, rails (782)push pawls (450) inwardly far enough such that pawls (450) disengagepawl notches (434). With pawls (450) disengaged from pawl notches (434),coupling (440) is disengaged from firing tube (420). With coupling (440)disengaged from firing tube (420), there is nothing to prevent coilspring (460) from decompressing. Coil spring (460) thus immediately andforcefully decompresses, rapidly pushing coupling (440) distally to fireneedle (110) via firing bar (730) and fork (732) as shown in FIG. 9D.Annular flange (442) and retainer (790) cooperate to arrest distalmovement of coupling (440) once coupling (440) reaches the firedposition shown in FIG. 9D.

In some versions, biopsy device permits the user to “soft fire” needle(110). For instance, in some such versions, motor (402) is activated tomove distally to translate firing tube (420) distally to the positionshown in FIG. 9A, to engage pawls (450). Motor (402) is then reversed totranslate firing tube (420), fork (732), needle (110), and associatedcomponents proximally to the position shown in FIG. 9B. However, insteadof continuing to rotate in that direction to continue translating firingtube (420) further proximally, to release pawls (450) and allow coilspring (460) to fire fork (732) and needle (110) distally, motor (402)again reverses to advance these components distally back to theconfiguration shown in FIG. 9A. In other words, motor (402) is used todrive fork (732) and needle (110) instead of using coil spring (460) todrive fork (732) and needle (110) distally. It should be understood thatsuch operation may allow the distal translation speed of fork (732) andneedle (110) to be controlled selectively, and may also allow the distalmotion of fork (732) and needle (110) to be interrupted, slowed or spedup, or otherwise controlled as fork (732) and needle (110) traverse adistal range of motion. Of course, such “soft fire” control may beprovided through one or more buttons (750, 760) and/or through any othersuitable form of control. It should be understood that, in someversions, a “soft fire” firing of needle (110) may be less audible tothe patient than firing of needle (110) by coil spring (460).

With needle (110) having been fired as shown in FIG. 9D (or as shown inFIG. 9A in “soft fire” operations, etc.), the user may then activatecutter actuation mechanism (202) to acquire one or more biopsy samplesfrom the patient's breast. In some versions, right after needle firingmechanism (400) has fired needle (110) distally, motor (402)automatically again reverses direction to move components from theconfiguration shown in FIG. 9D back to the configuration shown in FIG.9A, thus getting ready for a subsequent firing stroke. Alternatively,needle firing mechanism (400) may wait for a user to press arming button(760) before motor (402) reverses direction to move components from theconfiguration shown in FIG. 9D back to the configuration shown in FIG.9A. Other suitable ways in which biopsy device (10) may be used will beapparent to those of ordinary skill in the art in view of the teachingsherein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I claim:
 1. A biopsy device, comprising: (a) a needle having a tissuepiercing tip and an opening; (b) a body portion, wherein the needle islongitudinally movable relative to the body portion; and (c) a needlefiring assembly, wherein the needle firing assembly includes: (i) aresilient member configured to urge the needle distally relative to thebody portion when the resilient member is in a loaded configuration,(ii) a first translating member, and (iii) a second translating member,wherein the second translating member is secured relative to the needlesuch that the second translating member and the needle translateunitarily relative to the body portion, wherein the first translatingmember is movable distally toward the second translating member to loadthe resilient member, wherein the first and second translating membersare removably securable to each other to hold the resilient member inthe loaded configuration, wherein the first and second translatingmembers are movable proximally together while secured to each other,wherein the second translating member is configured to release from thefirst translating member when the first and second translating memberstogether reach a proximal position, wherein the loaded resilient memberis configured to drive the second translating member distally relativeto the first translating member upon release of the second translatingmember from the first translating member.
 2. The biopsy device of claim1, wherein the needle firing assembly includes a motor, wherein themotor is operable to selectively drive the first translating member inthe distal direction and in the proximal direction.
 3. The biopsy deviceof claim 2, wherein the first translating member and the secondtranslating member are operable to cooperatively drive the resilientmember into a compressed position as the first translating member isdriven in the distal direction by the motor.
 4. The biopsy device ofclaim 3, wherein the first and second translating members are configuredto maintain the resilient member in the compressed position as the firstand second translating members are moved proximally together whilesecured to each other.
 5. The biopsy device of claim 4, wherein the bodyportion includes a feature configured to release the second translatingmember from the first translating member when the first and secondtranslating members reach a proximal position, wherein the release ofthe second translating member from the first translating member allowsthe resilient member to decompress to fire the needle distally.
 6. Thebiopsy device of claim 5, wherein the feature configured to release thesecond translating member from the first translating member includes acam rail, wherein the first translating member includes an elongateslot, wherein the cam rail is disposed in the elongate slot.
 7. Thebiopsy device of claim 1, wherein the resilient member includes a coilspring.
 8. The biopsy device of claim 1, wherein the needle firingassembly further includes a firing rod and a fork, wherein the fork isremovably secured to the needle, wherein the fork is secured to thefiring rod, wherein the firing rod is secured to the second translatingmember such that the firing rod and fork are translatable relative tothe body portion.
 9. The biopsy device of claim 8, wherein the resilientmember is coaxial with the firing rod, wherein the resilient member andthe firing rod are parallel to the needle, wherein the resilient memberand the firing rod are laterally offset from the needle.
 10. The biopsydevice of claim 9, wherein the second translating member includes atleast one resiliently biased pawl configured to selectively secure thesecond translating member to the first translating member.
 11. Thebiopsy device of claim 1, wherein the needle firing assembly furtherincludes a movable restriction member configured to restrict proximalmovement of the first translating member to selectively prevent firingof the needle firing assembly.
 12. The biopsy device of claim 11,wherein the restriction member includes a transverse bar, wherein thetransverse bar includes an obstruction feature and a clearance feature,wherein the obstruction feature is configured to arrest proximalmovement of the first translating member when the transverse bar is in afirst position and when the first translating member reaches a firstproximal position, wherein the clearance feature is configured toprovide clearance for the first translating member to move to a secondlongitudinal position when the transverse bar is in a second position,wherein the second longitudinal position is proximal to the firstlongitudinal position.
 13. The biopsy device of claim 12, wherein therestriction member further includes at least one resilient memberconfigured to bias the transverse bar to the first position.
 14. Thebiopsy device of claim 1, wherein the first translating member includesa firing tube.
 15. The biopsy device of claim 14, wherein at least aportion of the resilient member is disposed within the firing tube. 16.A biopsy device, comprising: (a) a needle having a tissue piercing tipand an opening; (b) a body portion, wherein the needle is longitudinallymovable relative to the body portion; and (c) a needle firing assembly,wherein the needle firing assembly includes: (i) a resilient memberconfigured to urge the needle distally relative to the body portion,(ii) a translating member, wherein the translating member is operable tocompress the resilient member when the translating member is moveddistally, and (iii) a coupling assembly, wherein the coupling assemblyis selectively attachable to the translating member to hold theresilient member in a compressed configuration.
 17. The biopsy device ofclaim 16, wherein the needle firing assembly further includes a motor,wherein the motor is operable to drive the translating member distallyrelative to the body portion to secure the translating member and thecoupling assembly thereby placing the resilient member in the compressedconfiguration.
 18. The biopsy device of claim 17, wherein the motor isfurther operable to drive the translating member proximally to a firstproximal position while the translating member and coupling assembly areattached to each other, wherein the motor is further operable to drivethe translating member proximally to a second proximal position todetach the translating member and the coupling assembly, to thereby firethe needle distally.
 19. The biopsy device of claim 16, wherein thetranslating member includes a threaded region, wherein the needle firingassembly further includes a nut rotatably coupled with the motor,wherein the nut has threading complementing the threaded region of thetranslating member.
 20. A method of operating a biopsy device, whereinthe biopsy device comprises a needle, a body portion, a firsttranslating member, a second translating member, and a resilient member,wherein the needle, the first translating member, and the secondtranslating member are translatable relative to the body portion,wherein the second translating member is secured relative to the needlesuch that the needle and the second translating member translateunitarily, the method comprising: (a) advancing the first translatingmember distally relative to the body portion to load the resilientmember; (b) coupling the first translating member with the secondtranslating member; (c) retracting the first and second translatingmembers proximally relative to the body portion to a proximal position,wherein the resilient member remains loaded during the act ofretracting; and (d) releasing the second translating member from thefirst translating member when the first and second translating membersreach the proximal position, thereby firing the second translatingmember distally relative to the body portion under the influence of theloaded resilient member.